Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DPM — Predicate Candidate Screening

16 FDA 510(k) clearances under this product code; the 50 most recent screened below.

52 daysmedian FDA review time
95 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952501TOX PERFECT B TUBES AND REAGENTSChimera Research & Chemical, Inc.1995-08-24860
K895105HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USEWaters Chemical Products1989-10-06520
K894141LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1989-08-21690
K891673ADVANCED PURIFICATION GLASS COLUMNWaters Chemical Products1989-04-26360
K884403LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBESupelco, Inc.1988-12-22640
K881868LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARDSupelco, Inc.1988-08-291180
K880724LIQUID CHROMATO. COLUMNSSupelco, Inc.1988-05-27950
K864267SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)Millipore Corp.1987-01-09720
K862541LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1986-07-29260
K861633LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1986-05-23240
K842909LIQUID CHROMATOGRAPHY COLUMNS;ION EXCHSupelco, Inc.1984-10-05720
K832200PRP-1 REVERSED PHASE COLUMNS FOR HPLCHamilton Co.1983-08-16400
K813575LIQUID CHROMATOGRAPHY (HPLC) COLUMNSSupelco, Inc.1982-01-18260
K811304LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1981-05-27160
K802703LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1980-11-12120
K761168MAX L SYSTEMBrinkman Instruments, Inc.1976-12-1090

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda